MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

Device Problems Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that an unexpected no flow reading and alarm with an unknown error message occurred on the rotaflow console.The hand crank was used and the rotaflow and drive was replaced.But the problem reoccurred about an hour and a half later.After that the consumable was then replaced and the system (second unit) has not alarmed and works as expected.The affected disposable will be handled in complaint (b)(4).The affected rotaflow console and drive has been tested by a biomed (authorized person in the hospital).As it approached 1000rpms the ¿head error¿ occurred and is no longer operable.The reported head error will be handle in complaint (b)(4).No indication of actual or potential for harm or death has been reported.This event is related with complaint (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in canada.It was reported that an unexpected no flow reading and alarm with an error message, which the customer did not remember which one was displayed, occurred on the rotaflow console.The hand crank was used and the rotaflow and drive was replaced.But the problem reoccurred about an hour and a half later.After that the consumable was replaced the rotaflow system worked as expected.The affected disposable will be handled in complaint ot (onetrack) 471111.The affected rotaflow console and drive has been tested by a biomed (authorized person in the hospital).As it approached 1000rpms the ¿head error¿ occurred and is no longer operable.The reported "head error" will be handle in complaint ot (b)(4).No indication of actual or potential for harm or death has been reported.A getinge field service technician trouble-shooted the rotaflow console with s/n (b)(6) and rotaflow drive with s/n (b)(6) and could not confirm the reported failures" no flow reading and the displayed error message".The technician was able to read the flow with different rotaflow drive´s on the affected console with no error message.Based on these information the reported failure "no flow reading and error message" could not be confirmed.However, the failure mode "no flow reading and error message" can be linked to the following most possible root causes according to the risk management file (dms#2023689) possible causes for "no flow reading": - zero flow calibration failed; - incorrect flow measurement.Possible causes for "error message": - defective motor control electronics; - pump stop intervention after technical error (e.G.Pump runaway, error head); - sensor error (bubble, level, pressure (in hl20 mode), flow); - unintended rpm change by user; - unintended switch off by user.The review of the non-conformities was performed on 2021-05-31 and during the period of 2010-04-01 to 2021-05-31 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2010-04-01.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11906945
• MDR Text Key: 256197850
• Report Number: 8010762-2021-00326
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2021
• Patient Sequence Number: 1